Table 5. Induction of HER2-specific cell-mediated immunity.
|
Follow-up (weeks) |
||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Cohort | Allocation no | 0 | 6 | 8 | 10 | 12 | 16 | 20 | 24 | |
| 1 | 101 | Unpulsed | 3 | 20 | 8 | 17 | 37 | 42 | n/a | n/a |
| Stimulation | 3 | 95 | 44 | 37 | 73 | 37 | n/a | n/a | ||
| + or − | − | + | + | + | − | − | n/a | n/a | ||
| 102 | Unpulsed | 34 | 3 | 3 | 0 | 1 | n/a | n/a | n/a | |
| Stimulation | 57 | 32 | 13 | 0 | 0 | n/a | n/a | n/a | ||
| + or − | − | + | + | − | − | n/a | n/a | n/a | ||
| 103 | Unpulsed | 0 | 0 | 18 | 1 | 0 | 5 | 0 | 0 | |
| Stimulation | 0 | 0 | 21 | 3 | 8 | 11 | 9 | 0 | ||
| + or − | − | − | − | − | + | + | + | − | ||
| 2 | 201 | Unpulsed | 8 | 20 | 3 | 158 | 3 | 49 | 38 | 71 |
| Stimulation | 14 | 18 | 5 | 81 | 8 | 25 | 20 | 103 | ||
| + or − | − | − | − | − | + | − | − | − | ||
| 202 | Unpulsed | 4 | 2 | 4 | n/a | n/a | n/a | n/a | n/a | |
| Stimulation | 7 | 8 | 4 | n/a | n/a | n/a | n/a | n/a | ||
| + or − | − | + | − | n/a | n/a | n/a | n/a | n/a | ||
| 203 | Unpulsed | 2 | 19 | 12 | 2 | 7 | n/a | n/a | n/a | |
| Stimulation | 2 | 11 | 12 | 15 | 14 | n/a | n/a | n/a | ||
| + or − | − | − | − | + | + | n/a | n/a | n/a | ||
| 3 | 301 | Unpulsed | 15 | 23 | 9 | 30 | 1 | 22 | 9 | 4 |
| Stimulation | 18 | 20 | 22 | 48 | 1 | 8 | 11 | 7 | ||
| + or − | − | − | + | − | − | − | − | − | ||
| 302 | Unpulsed | 31 | 14 | 10 | 3 | 51 | 13 | 8 | 29 | |
| Stimulation | 19 | 21 | 16 | 9 | 33 | 38 | 30 | 31 | ||
| + or − | − | − | − | + | − | + | + | − | ||
| 303 | Unpulsed | 70 | 46 | 7 | 31 | 3 | 9 | 50 | 43 | |
| Stimulation | 37 | 10 | 82 | 17 | 5 | 6 | 49 | 64 | ||
| + or − | − | − | + | − | − | − | − | − | ||
CMI against HER2 was measured with an IFN-γ ELISPOT assay using fresh peripheral blood mononuclear cells from subjects at baseline and weeks 6, 8, 10, 12, 16, 20, and 24. Specific CMI to HER2 was induced with more than sixfold higher level compared to an unpulsed control in four subjects (102, 103, 203, and 303). Cells unpulsed with peptides served as negative control (mock). A positive response was defined as ≥5 spot-forming cells per well and a twofold or greater increase compared with the negative control.
n/a, not available due to withdrawal.